Regulatory Updates

State: All

Date Proposed : 10/1/2020

Program: Pharmacy

We are pleased to have reached this important milestone and continue our collaborative efforts with states and other stakeholders to protect patients from the potential risks associated with poor quality compounded drugs, while ensuring appropriate access to compounded drugs for patients that have a medical need for them. The availability of our standard memorandum of understanding (MOU) for signature by the states will help enhance communication and maximize our federal and state resources for oversight of compounded drugs produced by traditional compounding pharmacies.

State: All

Date Proposed : 09/19/2021

Program: Hospice

Hospice is an increasingly important benefit for the Medicare population. The goals of hospice care are to make terminally ill patients, with a life expectancy of 6 months or less, be as physically and emotionally comfortable as possible and to support their families and other caregivers throughout the process. Medicare patients who elect hospice care are an especially vulnerable population. They have the right to be free from abuse, neglect, mistreatment, and misappropriation of patient property. When hospices cause harm or fail to prevent or mitigate harm caused by others, patients are deprived of these basic rights.

State: Maryland

Date Proposed : 10/14/2019

Date Effective : 01/1/2020

Program: Home Health

CR 11330 will enable all Medicare-enrolled nurse practitioners in Maryland to certify home health services for Medicare beneficiaries as part of the Maryland Total Cost of Care (TCOC) Model. This will apply to services that the nurse practitioners provide on and after January 1, 2020. Medicare systems will be operational to process claims with dates of service on or after January 1, 2020, at the beginning of the second year of the Maryland TCOC Model. Make sure your billing staffs are aware of these changes.

State: All

Date Proposed : 12/10/2019

Program: Behavioral Health, Durable Medical Equipment, Prosthetics, Orthotics, and Supplies, Home Infusion Therapy, Private Duty

This special MLN Matters® Article is intended for entities seeking accreditation to become qualified suppliers that furnish home infusion therapy (HIT) services in coordination with the furnishing of home infusion drugs administered through an item of durable medical equipment (DME) beginning in calendar year 2021 and in subsequent years.

State: Florida

Date Proposed : 01/1/2021

Program: Home Health, Hospice, Pharmacy, Private Duty, Sleep

Each health care practitioner licensed by one of the named Boards in section 456.0341, Florida Statutes, must post a sign regarding human trafficking in a conspicuous place accessible to employees by January 1, 2021. The sign must be at least 11 X 15 inches and in at least 32-point type. The sign must contain statutorily required language and be posted in English and Spanish. The Department of Health has also provided Mandarin and Creole translations of these signs for use in offices where those languages are spoken. This effects Occupational Therapist, Physical Therapist, Respiratory Therapist, Registered Dietitian, Pharmacist.

State: All

Date Proposed : 09/4/2021

Program: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies, Home Health, Hospice, Pharmacy, Sleep

The ABN, Form CMS-R-131, and form instructions have been approved by the Office of Management and Budget (OMB) for renewal.  The use of the renewed form with the expiration date of 06/30/2023 will be mandatory on 8/31/2020. Update - Due to COVID-19 concerns, CMS is going to expand the deadline for use of the renewed ABN, Form CMS-R-131 (exp. 6/30/2023).  At this time, the renewed ABN will be mandatory for use on 1/1/2021.  The renewed form may be implemented prior to the mandatory deadline.